Label: SHOPKO ANTIBACTERIAL DEEP CLEANSING HAND- triclosan gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50988-450-00, 50988-451-00, 50988-452-00, 50988-453-00, view more50988-454-00 - Packager: Jets, Sets, & Elephants Beauty Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 28, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
- Directions
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Inactive Ingredients
Ocean Breeze
Acrylates copolymer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Cellulose, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Hydroxypropyl methylcellulose, Lactose, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, PEG-150 Distearate, Polysorbate 20, Retinyl Palmitate, Red 33, Silica, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tocopheryl Acetate, Ultramarines, Water (Aqua).
Cherry Blossom
Acrylates copolymer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Cellulose, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Hydroxypropyl methylcellulose, Lactose, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, PEG-150 Distearate, Polysorbate 20, Red 33, Retinyl Palmitate, Silica, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tocopheryl Acetate, Ultramarines, Water (Aqua), Yellow 5.
Warm Vanilla Sugar
Acrylates copolymer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Cellulose, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Hydroxypropyl methylcellulose, Lactose, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, PEG-150 Distearate, Polysorbate 20, Red 33, Retinyl Palmitate, Silica, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tocopheryl Acetate, Ultramarines, Water (Aqua), Yellow 5.
Dark Raspberry
Acrylates copolymer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Cellulose, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Hydroxypropyl methylcellulose, Lactose, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, PEG-150 Distearate, Polysorbate 20, Red 33, Retinyl Palmitate, Silica, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tocopheryl Acetate, Ultramarines, Water (Aqua), Yellow 5.
Red Pomegranate
Acrylates copolymer, Aloe Barbadensis Leaf Juice, Benzophenone-4, Cellulose, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, DMDM Hydantoin, Hydroxypropyl methylcellulose, Lactose, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, PEG-150 Distearate, Polysorbate 20, Red 33, Retinyl Palmitate, Silica, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Tocopheryl Acetate, Ultramarines, Water (Aqua), Yellow 5.
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INGREDIENTS AND APPEARANCE
SHOPKO ANTIBACTERIAL DEEP CLEANSING HAND
triclosan gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-450 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.2 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM CHLORIDE (UNII: 451W47IQ8X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) DMDM HYDANTOIN (UNII: BYR0546TOW) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) ULTRAMARINE BLUE (UNII: I39WR998BI) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50988-450-00 299 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/22/2012 SHOPKO ANTIBACTERIAL DEEP CLEANSING HAND
triclosan gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-451 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.2 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM CHLORIDE (UNII: 451W47IQ8X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) DMDM HYDANTOIN (UNII: BYR0546TOW) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) ULTRAMARINE BLUE (UNII: I39WR998BI) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50988-451-00 299 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/22/2012 SHOPKO ANTIBACTERIAL DEEP CLEANSING HAND
triclosan gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-452 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.2 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM CHLORIDE (UNII: 451W47IQ8X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) DMDM HYDANTOIN (UNII: BYR0546TOW) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) ULTRAMARINE BLUE (UNII: I39WR998BI) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50988-452-00 299 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/22/2012 SHOPKO ANTIBACTERIAL DEEP CLEANSING HAND
triclosan gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-453 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.2 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM CHLORIDE (UNII: 451W47IQ8X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) DMDM HYDANTOIN (UNII: BYR0546TOW) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) ULTRAMARINE BLUE (UNII: I39WR998BI) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50988-453-00 299 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/22/2012 SHOPKO ANTIBACTERIAL DEEP CLEANSING HAND
triclosan gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50988-454 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.2 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM CHLORIDE (UNII: 451W47IQ8X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) DMDM HYDANTOIN (UNII: BYR0546TOW) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) ULTRAMARINE BLUE (UNII: I39WR998BI) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) SULISOBENZONE (UNII: 1W6L629B4K) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50988-454-00 299 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/22/2012 Labeler - Jets, Sets, & Elephants Beauty Corp. (243254039) Establishment Name Address ID/FEI Business Operations Gold Orient International Limited 679905914 MANUFACTURE(50988-450, 50988-451, 50988-452, 50988-453, 50988-454)
